Who is the manufacturer of FACTOR II DEFICIENT SUBSTRATE PLASMA?

Helena Laboratories filed the 510(k) submission for FACTOR II DEFICIENT SUBSTRATE PLASMA (K834031).

What is the FDA product code for FACTOR II DEFICIENT SUBSTRATE PLASMA?

GGP. It is classified under 21 CFR 864.7290 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for FACTOR II DEFICIENT SUBSTRATE PLASMA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FACTOR II DEFICIENT SUBSTRATE PLASMA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FACTOR II DEFICIENT SUBSTRATE PLASMA

K834031 · Helena Laboratories · GGP · Dec 16, 1983 · Hematology

Device Facts

Record ID	K834031
Device Name	FACTOR II DEFICIENT SUBSTRATE PLASMA
Applicant	Helena Laboratories
Product Code	GGP · Hematology
Decision Date	Dec 16, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

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